Status:
COMPLETED
Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Gastrectomy
Malnutrition
Eligibility:
All Genders
25-75 years
Phase:
PHASE4
Brief Summary
Comparison of efficacy and safety of two lipid emulsion products will be performed on gastrectomy patients postsurgically.
Detailed Description
The comparison of two lipid emulsion product will be performed. Patients who plan to accept gastrectomy will be consider for trial and signed content will be obtained. If the patient needs total paren...
Eligibility Criteria
Inclusion
- Age between 25 \~ 75 years old
- Postoperative (gastrectomy) patients required parental nutrition for at least 5 days
- Signed informed consent form
Exclusion
- Known hypersensitivity to fish-, egg- or soy protein or to any of the active substances or excipients
- Known type IV hyperlipidemia, disturbances in lipid metabolism or hypertriglyceridemia. If the fasting S-triglyceride value at the time of inclusion is \>2.26 mmol/l (\>200 mg/dl) the subject must not be included
- Severe liver insufficiency (total serum bilirubin ≧ 3 mg/dL or parental nutrition as a contraindication.)
- Severe renal insufficiency with need for dialysis, chronic stable renal insufficiency defined as S-creatinine value of \>3mg/dL (250 µmol/l), or dialysis/hemofiltration therapy
- Over weight (BMI\> 30kg/m2)
- Severe blood coagulation disorders
- Inborn abnormality in amino acid metabolism
- Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration)
- Known diabetic ketoacidosis 7 days prior to randomization.
- Acute shock
- General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
- Pregnancy or lactation
- Chemotherapy within 7 days before start of the trial
- Participation in another clinical study with an investigational drug or an investigational medical device within 1 month prior to start of study or during the study
- Already accept parental nutrition therapy.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00885781
Start Date
November 1 2008
End Date
December 1 2010
Last Update
October 17 2011
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taipei, Taiwan, 10002